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Light Therapy in the Treatment of Leg Pain (MilCAM)

Primary Purpose

Tibial Fractures, Leg Injuries

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monochromatic Near-Infrared Light Energy (MIRE)
Sponsored by
Samueli Institute for Information Biology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Pain, Intractable, Infrared Rays, Leg

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Active duty soldier Exertional leg pain of greater than 3 months duration Documented bone scintigraphic evidence for tibial stress reaction or fracture Exclusion Criteria: Known leg Pathology other than stress reaction or fracture Service members known to be leaving area within next 6 months Pregnant females High risk cardiopulmonary patients Patients with assisted walking devices Patients with two or more cardiac risk factors

Sites / Locations

  • William Beaumont Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Infrared Light Therapy

Standard of Care

Arm Description

Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.

Standard of care was characterized by the use of standard medical treatment to include medication.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2005
Last Updated
May 10, 2016
Sponsor
Samueli Institute for Information Biology
Collaborators
William Beaumont Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00253981
Brief Title
Light Therapy in the Treatment of Leg Pain
Acronym
MilCAM
Official Title
Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Enrollment not achieved succesfully
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samueli Institute for Information Biology
Collaborators
William Beaumont Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
Detailed Description
Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology. Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures, Leg Injuries
Keywords
Pain, Intractable, Infrared Rays, Leg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infrared Light Therapy
Arm Type
Experimental
Arm Description
Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Standard of care was characterized by the use of standard medical treatment to include medication.
Intervention Type
Device
Intervention Name(s)
Monochromatic Near-Infrared Light Energy (MIRE)
Intervention Description
Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active duty soldier Exertional leg pain of greater than 3 months duration Documented bone scintigraphic evidence for tibial stress reaction or fracture Exclusion Criteria: Known leg Pathology other than stress reaction or fracture Service members known to be leaving area within next 6 months Pregnant females High risk cardiopulmonary patients Patients with assisted walking devices Patients with two or more cardiac risk factors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LTC Richard P Petri, MD
Organizational Affiliation
Department of the Army
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States

12. IPD Sharing Statement

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Light Therapy in the Treatment of Leg Pain

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